ClinicalTrials.gg
RecruitingNCT04026386Updated Nov 5, 2026

A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

An interventional study of Center Based or In Home Early Intervention Program in Development Disorder, Child, Developmental Disability and Development Delay, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2019; still recruiting 7 years later.
Updated Nov 5, 2026Study contact changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
2 Years to 5 Years
Sex
All
01

Study summary

The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.

02

Conditions studied

  • Development Disorder, Child
  • Developmental Disability
  • Development Delay
  • Autism Spectrum Disorder
03

In context

Developmental Disabilities

230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.

This study's planned enrollment of 75 is above the median of 60 across 150 interventional studies indexed under Developmental Disabilities.

Browse Developmental Disabilities studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
  • Boys and girls between 2.0 years and 5.11 years at time of enrollment;
  • Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.

Exclusion criteria

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
  • Lack of availability during program hours.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Center Based or In-Home Early Intervention Program

    Behavioral: Center Based or In Home Early Intervention Program

Interventions

  • BehavioralCenter Based or In Home Early Intervention Program

    This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment or in home to treat social communication deficits in children with developmental disorders.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.

    Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )

    Time frame: Baseline, 12 Weeks

Secondary outcomes

  1. Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.

    Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)

    Time frame: Baseline, 12 Weeks

  2. Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.

    Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).

    Time frame: Baseline, 12 Weeks

  3. Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.

    Time frame: Baseline, 12 Weeks

  4. Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.

    Time frame: Baseline, 12 Weeks

  5. Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.

    Time frame: Baseline, 12 Weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Contact
Study contact changed: P•••@stanford.edu · •••1235→r•••@stanford.edu · •••1235. See the current contact
Nov 5, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Stanford University School of Medicine · Stanford, United StatesContact P•••@stanford.edu · •••1235→P•••@stanford.edu · •••1235
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Contact Study contact changed: P•••@stanford.edu · •••1235→r•••@stanford.edu · •••1235. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Stanford University School of Medicine · Stanford, United StatesContact P•••@stanford.edu · •••1235→P•••@stanford.edu · •••1235
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04026386
Collaborators
John & Marcia Goldman Foundation
Responsible party
Antonio Hardan (Professor, Stanford University) — Principal investigator
First posted
Jul 19, 2019
Start date
Oct 19, 2019
Primary completion
Dec 30, 2034 (estimated)
Completion
Dec 30, 2034 (estimated)
Last update
Nov 5, 2026

Study contacts

Beatrice Begley, BS
Contact
PALprogram@stanford.edu
(650) 736-1235
Robin Libove, BS
Contact
rlibove@stanford.edu
(650) 736-1235
Antonio Hardan, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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